The efficacy and safety of brexanolone in post-partum depression: A systematic review

Introduction: Post-partum depression (PPD) affects women in the perinatal period, negatively impacting both maternal and neonatal wellbeing. As it is associated with suicidal tendencies it is important to not only identify this condition but also treat it. Fluctuations/sudden decrease in the levels of allopregnanolone, a neuroactive steroid has been implicated in the pathogenesis of PPD. Brexanolone, an intravenous formulation of allopregnanolone, in phase 1 and phase 2 trials has shown promising results in alleviating the symptoms of PPD. This systematic review is an attempt to evaluate the efficacy and safety of brexanolone in women with PPD.
Methodology: Online database search using key words: brexanolone, postpartum depression, safety, efficacy, clinical trials after establishing inclusion and exclusion criteria yielded 16 studies. Only 5 were selected as rest were review articles. Patients with postpartum depression of ≤ 6 months with baseline HAM-D score ≥20 were included in this systematic review. The CGI, HAMD-A/S, HAM-D (insomnia) scores, dose of brexanolone, time and duration of treatment, evaluation of safety and efficacy and the duration of follow-up were analysed.
Results: HAM D scores showed response to treatment with 50% reduction in score. Some studies showed improvement in CGI, HAMD-A/S, HAM-D (insomnia) scores as well. Very few side effects like headache, dizziness, somnolence, infusion site discomfort were reported.
Conclusion: Other than two serious adverse events seen at higher dose, brexanolone as a treatment option appears safe. It’s ability to improve the HAM-D score underlines its potential as a treatment for PPD.